Optimization of Diclofenac Sodium Orodispersible Tablets with Natural Disintegrants using Response Surface Methodology

Abstract

Traditionally experimental methods in the pharmaceutical formulation development involve significant amount of time and efforts to get an optimized dosage form. It is very much desirable as per industrial perspective to obtain suitable, optimized and stable formulation with minimum amount of time and effort. The purpose of this study was to study the synergic effect of natural disintegrants and central composite design in optimization of diclofenac sodium orodispersible tablets. In this study, central composite design was applied to study the effect of natural disintegrant as independent variables i.e. seed mucilage of Plantago ovata, and seed mucilage of Ocimum basilicum. Diclofenac sodium orodispersible tablets were prepared by direct compression method on Cadmech single punch machine using flat 8-mm punches and characterized for the dependent variables like disintegration time and cumulative percent drug released after 25 minutes. Optimization study by multiple regression analysis revealed that, 6% of Plantago ovata and 5% Ocimum basilicum was found to be optimum which has disintegrated in 36 secs and cumulative percent drug released was 99.2% at 25 minutes. A checkpoint formulation was prepared to prove the validity of the evolved mathematical model. These findings suggest that synergic effect of natural disintegrants of Plantago ovata and Ocimum basilicum employed with systematic experimental design approach have greater influence in optimization of diclofenac sodium orodispersible tablets. It is likely that this formulation technology can be exploited for commercial production of dispersible tablets.